SPECIAL PROCEDURES FOR CERTAIN TYPES OF REGISTRATIONS
A. INTRODUCTION TO SPECIAL PROCEDURES
B. SECTION 24C - SPECIAL LOCAL NEED (SLN)
C. SECTION 18 - EMERGENCY EXEMPTION
D. SECTION 5 - EXPERIMENTAL USE PERMIT (EUP)
E. SPRAY ADJUVANT, CALIFORNIA-ONLY
F. SECTION 25(b) EXEMPTED REGISTRATION
G. INTERIM REGISTRATION (AB 771)
H. EMERGENCY REGISTRATION (SB283)
I. RESEARCH AUTHORIZATION (RA)
Appendix VII-1 Section 24(c) DPR Request Form
Appendix VII-2 Comparison Chart, Section 24(c) and Section 18
Appendix VII-3 First Party Section 24(c) Paper Distribution
Chapter VII
SPECIAL PROCEDURES FOR CERTAIN TYPES OF REGISTRATIONS
A. INTRODUCTION TO SPECIAL PROCEDURES
This section identifies only the information and procedures which are unique to certain types of registrations.
The general procedures, data, and label requirements for these and other registrations are found in previous chapters.
The exception is the Research Authorization (RA) which is presented here in its entirety.
B. SECTION 24C - SPECIAL LOCAL NEED (SLN)
A Section 24(c) registration is also referred to as a Special Local Need or SLN registration. A state may issue a Section 24(c) to meet a special local need in the state.
Federal Authority.
In accordance with Section 24(c) of federal law FIFRA, each state is authorized to register a new end-use product or an additional use of a federally registered pesticide product, provided that there is a special local need in the state and all of the following criteria are met. Use 40CFR Part 162 and the U.S. EPA 24(c) Guidance Document and the DPR Section 24(c) Workbook, for additional detail.
1. The use must be covered by the necessary residue tolerance, or exemption from the requirement of a tolerance.
2. U.S. EPA has not canceled, suspended, or denied the use of the pesticide.
3. The product cannot contain a new active ingredient not registered by U.S. EPA.
4. There is no other federally-registered product for the specific use requested, or there is no federally-registered product available in adequate quantities.
A Section 24(c) can be issued as a first-party registration or a third-party registration.
All 24(c) applications are processed by the designated 24C Registration Specialist. First-party registrations are issued to the registrant of the pesticide. Follow instructions in Appendix VII-3 for issuance, amendment, inactivation, and distribution of paperwork for a first-party Section 24(c).
Third-party registrations are those issued to someone other than the product registrant, such as a county agricultural commissioner or a grower association. The company whose product is to be listed on the third-party SLN is contacted and their consent obtained prior to issuance. Consult the Section 24(c) DPR Handbook for detailed information on specific tracking, label and data requirements for third-party registrations and for amending or inactivating a third-party Section 24(c).
The following must be submitted by the applicant of a Section 24(c).
Residue data may be required for Section 24(c) products when the request is for a food or feed crop. The requirement for residue data will be determined on a case by case basis. The Registration Branch Senior Chemist should be consulted with questions regarding the need for residue data.
Residue data is not required for crops grown for seed which comply with Ca Notice 96-7 (Section 12832), for active ingredients which are exempt from the requirement of a residue tolerance, or for food use that USEPA determined is within the "threshold of regulation TOR."Efficacy data is required to support the use.
Phytotoxicity data, if applicable, is required to support the use.
The designated Registration Specialist processes the request.
To verify that a U.S. EPA residue tolerance has been established (or an exemption from the requirement of a tolerance) for the active ingredient on the commodity, use the Pesticide Chemical News Guide and updates of Part 180 in 40CFR. Included in Part 180 are crop definitions used for purposes of a tolerance, regional tolerances, crop groupings, and exemptions from tolerance.
If the product is not already registered in California, complete data must be submitted and the package routed to all stations as a regular product registration.
If the above criteria are not met, the Section 24(c) request is returned to the applicant. See Chapter III on Returns.
If the submission is complete, route the package to the appropriate evaluators for scientific evaluation. Follow instructions in Chapter III on the evaluation process and 30-day posting. After the 30-day public notice period has elapsed, a final action can be taken.
Section 24(c) requests are not required to be routed to the Medical Toxicology branch unless the product is not currently registered in California. Only 24(c)s which have one, or more, of the following need to be routed to WH&S: (1) fumigant use; (2) specialized application methods such as fogging machines and pool or packing house injector systems; (3) self-contained breathing apparatus (SCBA) or supplied air respirators Worker or workplace monitoring requirement; (4) reduction of Personal Protective Equipment (PPE) or engineering controls; and (5) reduction of Restricted Entry Intervals (REI) or similar type exposure restrictions. All packages routed to WH&S must be approved by supervisor.
If the Section 24(c) can be issued, the designated Registration Specialist will:
Once issued, a Section 24(c) is in effect indefinitely, although it may be amended or inactivated. A Section 24(c) should be inactivated by DPR if the product is no longer registered in California. Section 24(c)s cannot be transferred.
U.S. EPA has 90 days to comment on the issuance of the Section 24(c).
Addition of subregistrant/distributor to the Section 24(c). All Section 24(c)s are based on the basic registrant's product. A currently registered subregistrant/distributor can be added to any Section 24(c) issued for the basic registrant's product, provided that the basic registrant agrees. The Section 24(c) label is amended to show the addition of the subregistrant/distributor's product. If an applicant's first request is for the subregistrant/distributor product to be authorized, the basic registrant's product (if registered in California) must also appear on the Section 24(c) label.
Advertising. Section 24(c) product uses cannot be advertised unless the criteria outlined in 40CFR are met.
A comparison chart of Section 24(c) and Section 18 is in Appendix VII-2.
C. SECTION 18 - EMERGENCY EXEMPTIONS
A Section 18 is an emergency exemption to allow use of a product against an emergency pest problem.
Federal Authority.
Section 18 of FIFRA allows the state to issue an emergency exemption if DPR and U.S. EPA agree that an emergency pest problem exists and there is no registered available alternative. Use 40CFR Part 166 and U.S. EPA's Section 18 Guidance Document and the DPR Section 18 Workbook.
There are four types of emergency exemptions: specific, quarantine, public health, or crisis. Most emergency exemptions are issued as "specific" Section 18s. A quarantine Section 18 is issued for three years and is to prevent the introduction or spread of a foreign pest into or throughout the United States. A public health exemption can be issued, but this provision is rarely used. A crisis exemption may be issued if the need is immediate and there is no time to obtain any of the other three types of Section 18s.
Emergency exemptions are for those uses for which no tolerance or exemption from tolerance has already been established. U.S. EPA will issue a time-limited tolerance (formerly called an action level) to allow harvest of crops treated under the exemption.
Note: Uses with existing residue tolerances or exemption from the requirement of a tolerance would be processed under Section 24(c). To verify that a U.S. EPA residue tolerance has or has not been established (or exemption from the requirement of a tolerance) for the active ingredient on the commodity, use the Pesticide Chemical News Guide and updates of Part 180 in 40CFR. Included in Part 180 are crop definitions used for purposes of a tolerance, regional tolerances, crop groupings, and exemptions from tolerance. Some food uses are determined in 40CFR 180.2010 to be within the "threshhold of regulation TOR."
The DPR Director may waive data requirements of Article 5 of the California Administrative Code.
The following must be submitted by the applicant of a Section 18 request. The applicant is always someone other than the product registrant.
A request for a Section 18 may be made by a county agricultural commissioner, grower association, private grower, farm advisor, or university personnel. The form must be signed by an agricultural commissioner. The request must include the name and phone number of a knowledgeable expert(s) that DPR and U.S. EPA may consult regarding the emergency. This generally is a farm advisor or U.C. Extension official.
Residue data sufficient for U.S. EPA to establish a time-limited tolerance.
Efficacy data to support the use.
Phytotoxicity data to support the use.
A detailed resistance management program, if pesticide resistance is the basis for the Section 18.
Section 18 requests are not required to be routed to the Medical Toxicology Branch, unless the product is not currently registered in California.
If the product is not currently registered in California, data such as toxicology and chemistry adequate to support the use must also be submitted. The submission is reviewed as a full product, requiring a full label and an application form with the statement of formula. Place the application form with the statement of formula into the product file in the Label Resource Center at time of issuance.
The designated Registration Specialist processes the Section 18 request.
If the submission is incomplete, the Section 18 request may be returned to the applicant. See Return procedures in Chapter III.
If the submission is complete, the Section 18 request enters the evaluation process. See Chapter III for instructions on preparing the package. Section 18 requests are given an expedited evaluation.
Section 18 emergency exemptions are posted for the 30-day public comment period although a Section 18 can be issued and used prior to, or during, the 30-day comment period.
If DPR supports issuance of the Section 18, the request is forwarded to U.S. EPA.
When the Section 18 exits evaluation, and the emergency use is justified, the designated Registration Specialist prepares a Section 18 request to be forwarded to U.S. EPA. The request letter and form must include the following information (see the DPR Section 18 Workbook for detail).
A copy of the proposed Section 18 "label" is given to the Enforcement Branch for comment.
If U.S. EPA grants the Section 18.
A telegram, e-mail, or fax is sent by U.S. EPA to DPR listing details of the exemption. DPR then issues the Section 18. U.S. EPA publishes the time-limited tolerance in the Federal Register.
The designated Registration Specialist sends copies of the Section 18 to the county agricultural commissioners, extension offices, departmental personnel, etc., as indicated on the Section 18 Distribution Sheet. Copies are also sent to any other requesting party.
Important: All uses under a Section 18 require a restricted materials permit from the agricultural commissioner prior to possession or use.
Section 18s are issued for one season, not to exceed one year (quarantine Section 18s are issued for three years). Reissuance may be requested if the emergency pest problem still exists.
Section 18s currently in effect in California are listed on the DPR home page.
Crisis Exemption
In some cases a crisis Section 18 may have to be issued. Federal law provides that states may authorize use of a pesticide in emergency conditions without obtaining U.S. EPA approval for a specific exemption, if the nature of the emergency is such that applications must be made before a specific exemption could be granted. The review processes are carried out expeditiously.
DPR must contact U.S. EPA at least 36 hours in advance of issuing a crisis Section 18. In no case can notice be given to U.S. EPA later than 24 hours after issuance. U.S. EPA faxes their approval. The crisis Section 18 is only authorized for 15 days, unless the state submits a specific Section 18 request. The treated crops may not be sold for consumption until U.S. EPA establishes a time-limited tolerance for the Section 18.
Advertising. Product uses issued under Section 18 cannot be advertised unless criteria outlined in 40CFR 168.22 are met.
A comparison chart of Section 18 and Section 24(c) is in Appendix VII-2.
D. SECTION 5 - EXPERIMENTAL USE PERMIT (EUP)
The U.S. EPA issues Section 5 experimental use permits (EUPs) to allow limited use of a product for data-gathering activities to accumulate the data necessary to register the product under Section 3.
An EUP is not required when (1) the experimental use of the pesticide is limited to (i) Laboratory or greenhouse tests or (ii) Limited replicated field trials as described in part 172.3 (c) of 40 CFR, and (2) the producer, applicator, or any other person conducting the test does not expect to receive any benefit in pest control from the pesticide's use.
If use of the product is on a food or feed crop, and there is no tolerance, U.S. EPA may establish a time-limited residue tolerance or exemption from tolerance before issuing the EUP. If there is no tolerance or time-limited tolerance (or exemption from tolerance), the food or feed derived from the experimental program must be destroyed or fed only to experimental animals. Time limited tolerances have become difficult to obtain, requiring crops to be destroyed and lessening the likelyhood of a person to obtain an EUP. DPR issues many more research authorizations than EUP registrations, due in part to the applicant's difficulty in receiving a time limited tolerance.
An EUP may be issued for a new active ingredient, a new product, or a new use of a currently registered product.
EUPs may be submitted concurrently to DPR and to U.S. EPA for review.
To use a federal EUP in California, a company must either register the EUP in California or use the EUP under a Research Authorization.
Once registered by DPR, the EUP label is treated the same as any other registered label in the state. Although it is not a typical conditional registration, an EUP is registered under CCR Section 6200, conditional registrations. It is conditional in terms of the parameters and restrictions of the EUP, such as amount of active ingredient to be used, acres to be treated, and expiration date.
The conditions of use in California are the same as those placed on the Federal EUP by U.S. EPA as follows:
To submit an EUP request to California, the following are needed:
The following items must appear on a EUP label:
Note: In the case of a registered pesticide, the U.S. EPA may permit a pesticide to be used under an EUP with supplemental labeling but such supplemental labeling must be approved
The Chemistry station evaluates only the EUP-required data listed in 40CFR and any environmental fate AB2021-type data that are submitted. They will not evaluate any other submitted data such as residue data for crops not listed on the EUP, storage stability data or other product chemistry studies not required for the EUP. Review of these types of data is deferred until the Section 3 submission is received. The Chemistry evaluator will indicate on the Data Index Report accompanying the package, the record numbers of those studies or tests for which a complete evaluation was done. This report will be attached to the evaluation memo.
When the Section 3 request is later submitted, both the Chemist and the Registration Specialist will be able to identify which studies have already undergone complete evaluation and will not have to be re-reviewed. The Registration Specialist will attach a copy of the Chemist's original memo and Data Index Report to the Section 3 package when it is submitted into evaluation. If it is not apparent whether or not a full review was done for certain studies, a full chemistry evaluation may have to be done upon receipt of the Section 3 submission.
No efficacy or phytotoxicity data is required for an EUP, but may be submitted if available.
Federal data requirements for EUPs are listed in 40CFR, Part 172 and the U.S. EPA Pesticide Assessment Guidelines, Subdivision I.
Upon issuance, the Registration Specialist will assign an EUP number such as 123-55000-EX. See Chapter III for instructions on assigning an EUP number and issuing the license.
Once registered, the pesticide product may be sold for the EUP uses, but is not available to the general public. The product can be sold only to specific cooperators designated as participants in the EUP program by the registrant, for the purpose of establishing research trials.
Product uses issued as Section 5 EUPs cannot be advertised.
Key Points:
E. SPRAY ADJUVANT, CALIFORNIA-ONLY
Spray adjuvants do not require U.S. EPA registration, but do require DPR registration under California law FAC 12753.
A spray adjuvant is defined as a pesticide in California and is subject to the registration requirements. A spray adjuvant is a product sold in a separate package and intended to be used with another pesticide to aid the application or enhance the activity of the pesticide.
Spray adjuvants can contain only ingredients which are exempt from U.S. EPA tolerance.
A spray adjuvant can be a wetting agent, spreading agent, deposit builder, adhesive emulsifying agent, deflocculating agent, water pH modifier, or similar agent, with or without toxic properties of its own, intended to be used with another pesticide as an aid to the application or effect of the other pesticide. Attractants labelled for use with a pesticide are included as spray adjuvants. Diluents are not spray adjuvants.
Spray adjuvant applications are handled by the designated Registration Specialist for the company applying for registration. This includes spray adjuvants that contain new active ingredients. Adjuvants containing new active ingredients will first be routed to the designated Program Specialist and flagged before they will be given to the Registration Specialist for processing. This flag will appear on the status sheet and removed from the system if the product is registered.
The label requirements are outlined in Chapter II. Adjuvants are not subject to labeling requirements outlined in U.S. EPA's PR-Notices unless such requirements are also required under California laws/regulations, since adjuvants are not considered pesticides under federal law.
The data requirements are as follows. It is advisable to confirm the requirements for each spray adjuvant product in advance.
1. Acute toxicity data.
This is required on the formulated product and includes oral, dermal, and inhalation toxicity values and the results of eye and skin irritation test. Chronic toxicology data are not required for spray adjuvants unless the acute toxicity studies indicate a risk of a chronic effect.
2. Chemistry data.
Physical and chemical properties of the ingredients active as a spray adjuvant. This includes information such as chemical identity, molecular weight (average molecular weight for polymers), physical state, melting point, boiling point, density or specific gravity, solubility in solvents and in water, and vapor pressure. Hydrolytic, thermal and/or acid and base stability may be requested if it appears that these properties may affect the use or storage of the adjuvant.
Statement of composition including all inert ingredients and their chemical identity.
Ingredients must be on U.S. EPA's list of acceptable inerts in 40CFR part 180, on the GRAS (Generally Regarded as Safe) list, or otherwise exempt from the residue tolerance requirement.
3. Efficacy data to support the label claims
pH control buffers: Data must show how much product is required to buffer 100 gallons of water having hardness equivalent to 175 ppm as calcium carbonate to the pH recommended on the label, except for swimming pool products. If no pH is recommended on the label, then pH may be used as the criteria, except for swimming pools. Buffering capacity for other pHs may be requested in some cases.
Drift Control: Data showing control achieved and giving conditions of the test must be submitted. For this requirement, data must show how many feet less the spray drifts when used at minimum label recommended rate, compared to without it. The trials with and without the drift control formulation must use the same equipment and conditions and preferably run on the same day. Alternative methods of demonstrating drift control that are acceptable to DPR may be used.
Adjuvants with Claims of Increased Pesticide Life: Residue data with and without the adjuvant from applications of a commonly used nonsystemic organophosphate and carbamate (also a pyrethroid and a nitro compound) are required to show how much the pesticide residue life is extended.
Adjuvants with Claims of Increased Pesticide Absorption: Residue absorption data, with and without the adjuvant from applications of a commonly used systemic herbicide, systemic organophosphate, and systemic carbamate are required to show how much increase there is in absorption.
To select the appropriate evaluation stations, use Appendix III-1.
If there is reason to believe the adjuvant will adversely affect the lifetime or toxicity of pesticide residues, or if other undesirable effects occur, additional data such as data on crop residue or worker exposure may be required.
Since spray adjuvants are not U.S. EPA regulated pesticides, DPR may request label changes. At a minimum, the label must indicate the ingredient statement, signal word, precautionary statements, use directions, and storage and disposal instructions.
Upon issuance, adjuvants are assigned a 50000 California Registration Number (Ca. Reg. No.) that immediately follows the company number and precedes the alpha code AA (ex. 123-50001-AA). In general, additional brand names for registered adjuvants should be given a unique product number rather than a new alpha code. However, should a special circumstance arise, a new alpha code may be assigned. If you feel you have a special circumstance, you should speak to your supervisor. If a U.S. EPA firm number has not been assigned, a California firm number will also be assigned. See Chapter III for instructions on assigning a Ca. Reg. No. and on Issuing a Product License.
For information regarding spray adjuvants that qualify for exemption under FIFRA section 25(b), please see the section for Section 25(b) Type Exempted Registrations.
F. SECTION 25(b) TYPE EXEMPTED REGISTRATIONS
California law has exempted certain pesticide products from the requirement to obtain registration. These products are still pesticides. However, if they meet the criteria outlined in FAC 12803 and CCR 6147, they are not required to obtain California registration. It should be noted that individuals, in the business of pest control for hire, that apply exempt products are subject to DPR's licensing requirements. Such products are exempt from pesticide use reporting.
The criteria and label requirements are outlined in DPR's California Notice to Registrants 2000-6. Because California exemption criteria are linked closely to U.S. EPA exemption criteria, U.S. EPA's PR Notice 2000-6 should also be used in conjunction with California's Notice 2000-6. Where U.S. EPA criteria and California criteria differ, the California criteria must be followed. At a minimum, all product labels must list the active ingredient(s) by name and percentage (by weight) and all inert ingredients by name. The total percentage by weight must equal 100%. The approved list of active ingredients can be found in CCR section 6147(a)(5) and all inert ingredients must be on U.S. EPA's most current List 4A "Inerts of Minimal Concern." These two lists are not interchangeable.
In some cases, a company will choose to register a product, even if it is exempt from requiring registration. For Section 25(b)-exempt products which the company chooses to register in California, the registration specialist will process it as a regular registration. The data requirements include acute toxicology, product chemistry, efficacy and phytotoxicity. Residue data may not be required since most are tolerance-exempt ingredients by U.S. EPA. In lieu of submitting the required studies, the applicant may request, in writing, a waiver. The justification for the waiver request is submitted with the package into the evaluation process. Upon issuance of registration for these products, the registration specialist will assign a Ca. Reg. No. if a U.S. EPA Reg. No. has not been assigned. See Chapter III for instructions on registering products, assigning a Ca. Reg. Number, and issuing the license.
| The following items are listed to clarify how we handle spray adjuvants that qualify for exemption under FIFRA section 25(b). | memo 3-9-06 |
1. Acceptance of Spray Adjuvants for Exemption
Spray adjuvants can qualify for exemption from registration provided the spray adjuvant product meets all of the criteria outlined in DPR's regulations.
2. Active Ingredients vs. Principle Functioning Agents
It is acceptable for the active and inert ingredients in a spray adjuvant to be listed as "Principle Functioning Agents" and "Constituents Ineffective as a Spray Adjuvant," respectively, on a spray adjuvant label. DPR considers the term "principle functioning agent" to be synonymous with the term "active ingredient," and the term "constituents ineffective as a spray adjuvant" to be synonymous with "inert ingredient," for purposes of exemption under CCR section 6147. To be exempt from registration, all principal functioning agents in the spray adjuvant product must be listed in CCR section 6147(a)(5), and all constituents ineffective as a spray adjuvant must be on U.S. EPA's most current List 4A "Inerts of Minimal Concern."
3. Labeling of a Spray Adjuvant for Exemption
All general labeling requirements as outlined in both 40 CFR, Part 152.25 and CCR section 6147 [see 6147 (a)(5)(D)] must be followed in order for a spray adjuvant to qualify for exemption. This means that spray adjuvant products must list all active ingredients (or principle functioning agents) by name and percentage (by weight), and all inert ingredients (or constituents ineffective as a spray adjuvant) by name on the product label. In addition, the product label must not include any false and misleading statements.
An Interim Registration may be issued for an agricultural use product which contains an active ingredient subject to the environmental fate (AB2021) requirement. Up to three of the specified data types may be lacking, but the submission must meet the following criteria as outlined in FAC Sections 13161 through 13170:
Field dissipation study.
Octanol water partition coefficient (Kow).
Efficacy data.
Soil photolysis.
A re-done environmental fate study to correct errors or a study conducted under California conditions, if all other data support a decision for Interim registration.
All other required data have been submitted and found acceptable.
Information that the product is part of a pest management system as outlined in the Ca Notice 94-7.
A commitment to submit the deferred data, including a schedule of quarterly progress reports.
A $5000 application fee per registration action (except additional brand names) in addition to the required $750 product application fee.
The PREC (Pesticide Registration and Evaluation Committee) must be consulted. After consultation, a written finding is prepared for the director's signature.
The certificate of Interim Registration specifies which data are being deferred, a time frame for submission not to exceed three years, and any limitations on the use deemed appropriate.
The process for an Interim Registration is separate and independent of the "conditional registration" process.
An Emergency Registration may be issued for products previously used under a Section 18 as allowed by FAC Section 12833. The most significant aspect is that the evaluation process need not be completed prior to issuance.
The criteria for issuance of an Emergency Registration are as follows:
An Emergency Registration is separate and independent of a Section 18, although a previous Section 18 is one of the criteria.
I. RESEARCH AUTHORIZATION (RA)
The purpose of California Research Authorization (formerly known as California EUP) is to gather data on efficacy, phytotoxicity, residue, environmental effects, methods of application, or other field data to support California registration.
An RA is a permit and not a registration. An RA is not routed through the evaluation process; applications for permits are made directly to the Plant Physiologist who is responsible for issuing RAs. RAs allow companies to develop data under California use conditions.
The Plant Physiologist will determine the parameters of use such as number, size, location of trials, etc. Under an RA, the product cannot be sold for the experimental use, but must be provided free of charge to any cooperator whose property is being used for experimental trials. If there is no residue tolerance or exemption from a tolerance, the treated commodity cannot be used for food or feed.
Limited acute toxicity data are required for pesticide products not registered in California.
A company may request an RA by submitting a completed RA application form.
The following pertain to issuance of an RA:
If a registrant has a Federal EUP which is not registered in California, an RA may be issued for that use, provided the proposed trials are consistent with the parameters of the federal EUP. Restrictions may be imposed on the size of the experimental trials permitted under the RA. Detailed questions involving RAs should be referred to the Plant Physiology office.
Key Points:
| J. MASTER LABELS | CA Notice 2006-10 |
A Master Label is defined as a pesticide product label that bears most of or all U.S. EPA approved uses, however the company does not intend to market that label for sale or use in California. Master Labels may include, but are not limited to the following examples: labels submitted in Word document format, labels containing multiple storage and disposal statements for use on various sized label containers, verbiage such as "Supplemental distributors may choose from the following language," or verbiage contained in brackets indicating optional label language. Such items would not be included on a marketing label. Master Labels are not required to be in final printed or printer's proof format as they will not be distributed, sold, or used in California. If the submitted label appears to be a Master Label, and the registrant does not indicate in their cover letter that they are submitting a Master Label, the Registration Specialist should check with the registrant to determine their intent before proceeding with the registration or amendment.
As of July 28, 2006, all Master Labels require registration in California. Each new Master Label must be accompanied by all items applicable to a new product registration such as, a completed application form, six copies of the label, a $750 application fee, etc. For instructions on how to register a product, please see Chapter 3.
If the label is acceptable and the submission complete, the specialist should stamp the label using a designated
Master Label stamp. This stamp indicates that the label is not intended for sale or distribution in the State of
California. Licensing will record the brand name of the product on the license and in DPR’s product database using
the prefix “Master Label - (Brand Name).” The addition of the prefix will distinguish a Master label from a marketing
label with the same brand name. In addition, all Master Labels will be assigned the alpha code “ML.” (For example:
“Master Label - XX Insecticide, EPA Reg. No. XXX-XX-ML.”) This will allow both internal and external users of DPR’s
databases to identify Master Labels. At the end of each calendar year, a $750 renewal fee will be required for
each Master Label. In addition, the $100 amendment fee will apply to each submission of a substantive amendment
to a Master Label.
Appendix VII-2
Comparison Chart, Section 24(c) and Section 18
Sections 24(c) and 18 of FIFRA authorize states to allow an additional use of a product, without the manufacturer first going through U.S. EPA if the following criteria are met.
|
Section 24(c) |
Section 18 |
| 1. Tolerance or exemption already established. | 1. No tolerance yet established. U.S. EPA will establish a time-limited tolerance. |
| 2. Justification and lack of alternatives must be documented. | 2. Emergency situation must be documented - not historical pest problem (economics and lack of alternatives must be verified). |
| 3. Data - efficacy, phytotoxicity. Residue requirement was discontinued in 2004 | 3. Data - residue, efficacy, phytotoxicity. |
| 4. Scientific evaluation. | 4. Scientific evaluation. |
| 5. Letter of authorization from manufacturer. | 5. Letter of authorization from manufacturer. |
| 6. Post for comment. | 6. Post for comment although not technically required. Write justification to U.S. EPA and wait for approval which includes the use, limitations on acreage and location, and the time-limited tolerance. |
| 7. Issued without expiration date, although can be inactivated. | 7. Expiration date (not to exceed one year). |
| 8. May be third-party or first-party. | 8. Must be third-party. |
| 9. Must pay U.S. EPA maintenance fee. | 9. No U.S. EPA maintenance fee. |